1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The Study of Effect of a 24-Weeks Period of Elastic Resistance Band Training on Biomarkers of Osteosarcopenia Obesity in Osteosarcopenic Obese Women
Protocol summary
Study aim
Determining the effect of 24 weeks resistance training with elastic cache on serum sclerostine levels and with elastic cuffs on serum levels of troponin T in elderly women with osteosarcopenic obesity
Design
Randomised, Clinical trial, control and intervention groups
Settings and conduct
This is an applied clinical study in the field of elderly medicine and exercise.Patient sampling is done at Hagar Hospital and in the city's health clinics.Sports exercises and follow up of the control group at Pars Rehabilitation Center.Exercises are provided by the trained sports instructor.Each person receives a bone scan (DXA) and a blood sample at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age over 65 years old;Fat percentage greater than 32% or BMI greater than 30%;T-score <
-1.0; The power of the Handgrip Strength is less than 21kg in the age range of 65 to 80 years Exit
criteria:Chronic diseases such as high blood pressure;
thyroid disease; severe kidney disease, cancer, diabetes or ,osteoporosis (T-score < -2.5); Parallel Physical Exercises ;Following a weight loss diet of more than 5kg in the last three months; Hormone therapy or taking any medication that affects bone density, fat tissue, or hormonal system.
Intervention groups
Participants in the intervention group participate in a special training program. Participants are requested to conduct a sports protocol during the course of the study.
Participants in both groups are asked to continue their previous food program.
Main outcome variables
Serum levels of sclerostin; Serum levels of troponin T
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20180627040260N1 Registration date: 2018-11-27, 1397/09/06
Registration timing: registered_while_recruiting
Last update: 2018-11-27, 1397/09/06 Update count: 0
Registration date 2018-11-27, 1397/09/06 Registrant information
Name
Mohammadali Dayani Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 38 3224 4194 Email address
dayani@skums.ac.ir Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2018-11-22, 1397/09/01
Expected recruitment end date 2018-12-22, 1397/10/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
2 Scientific title
The Study of Effect of a 24-Weeks Period of Elastic Resistance Band Training on Biomarkers of
Osteosarcopenia Obesity in Osteosarcopenic Obese Women
Public title
Effect of Elastic Resistance Band Training on Biomarkers of Osteosarcopenia obesity
Purpose Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Age over 65 years old, Fat percentage greater than 32%
or BMI greater than 30%, T-score < -1.0, The power of the Handgrip Strength is less than 21kg, Age range of 65 to 80 years
Exclusion criteria:
Chronic diseases such as high blood pressure, thyroid disease, severe kidney disease, cancer, diabetes or ,osteoporosis (T-score < -2.5) Parallel Physical Exercises Following a weight loss diet of more than 5kg in the last three months Hormone therapy or taking any medication that affects bone density, fat tissue, or hormonal system.
Age
From 65 years old to 80 years old Gender
Female Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 60
Randomization (investigator's opinion) Randomized
Randomization description
After completing the initial evaluations, subjects are randomly assigned to the training or control group in a 1:
1 ratio using block randomization based on age (60 to 80 years) (stratified blocked randomization) using
Unspecified seal envelopes are assigned. A research assistant, not directly involved in the evaluation, generates block size and random sequences using a computer that is hidden from the study researcher.
Blinding (investigator's opinion) Not blinded
Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Educational Complex of Shahrekord University of Medical Sciences, Rahmatieh,Shahrekord City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
88155571 Approval date
2018-04-22, 1397/02/02
Ethics committee reference number IR.SKUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied Oosteo sarcopenic obesity syndrome ICD-10 code
ICD-10 code description
Primary outcomes
1
Description troponin t Timepoint
24 hours before the intervention and 48 hours after the end of the workout
Method of measurement ELISA KIT,96 WELLS
2
Description Sclerostin Timepoint
24 hours before the intervention and 48 hours after the end of the workout
Method of measurement ELISA KIT,96 WELLS
Secondary outcomes empty
Intervention groups
1
Description
Intervention group: Individuals in the intervention group participate in a special training program. Participants in
3 both groups are asked to continue their previous diet.
The personalized training program using rubber bands (Thera-Band®, The Hygenic Corporation, Akron, OH, USA) is a two training sessions per week course for the duration of 24 weeks which leads to a total of 48 sessions. The program will include 10 minute warm-up and cool down stretching exercises at the beginning and end of each training session. Each session will be a 60 minute resistance training using rubber bands (the extent and intensity of exercise will be increased over the time). Intend resistance exercises will be the alternative training of upper and lower body large muscles. Using rubber bands will cause the needed resistance overload. This type of resistance loading is chosen for both ease of use and performance, also it is suitable for elderly people who did not previously engage in physical activities. Intensity of loading was adjusted using color coded rubber bands (based on strengths yellow, red, green and blue). Intensity of initial resistance load for each individual was chosen based on their ability to do 15-20 repetitions. Each two weeks the training program is reviewed and if the individuals can do 30 repetitions the strength of rubber band will be increased.
Each resistance session of training with rubber bands would also include exercising one or two groups of major muscles (legs, back, stomach, chest, shoulders, and arms). These exercises include: seated rowing exercise, standing body rotation, squat, leg press, crunching, preacher curls with two hands, lateral flexion, triceps extension, bench press, and dorsiflexion of ankles.
Completion of all ten mentioned exercises is counted as one cycle. To induce standard resistance, rubber band should be stretched to 100% of rest lengths. Training speed of each internal and external phase of sessions should be 4seconds. Each session consists of 3 cycles.
Category
Treatment - Other
2
Description
Control group: The control group only performs daily activities.Participants are asked to continue their past food program
Category N/A
Recruitment centers
1
Recruitment center
Name of recruitment center Ayatollah Kashani Hospital Full name of responsible person
Mohammadali Dayani Street address
Parastar Street,Shariati
Blvd,Shahrekord,Chaharmahal & Bakhtiari Province City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
۸۸۱۶۷۵۸۹۱۵ Phone
+98 38 3226 4825 Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences Full name of responsible person
Sayyed Kamal Solati Street address
Headquarters of the University,Kashani BLVD,shahrekord
City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
۸۸۱۵۷۱۳۴۷۱ Phone
+98 38 3334 2414 Email
vcrt@skums.ac.ir Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences Proportion provided by this source
100
Public or private sector Public
Domestic or foreign origin Domestic
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding Academic
Person responsible for general inquiries
Contact
Name of organization / entity The University of Shahrekord Full name of responsible person
Ebrahim Banitalebi Position
Associate Professor Latest degree
Ph.D.
Other areas of specialty/work Exercise Physiology
4 Street address
Rahbar Blvd, Shahrekord University, City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
۳۴۱۴۱۸۸۱۸۶ Phone
+98 383232440 Email
banitalebi.e@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences Full name of responsible person
Mohammadali Dayani Position
Assistent Professor Latest degree
Specialist
Other areas of specialty/work Radiology
Street address
Parastar Street,Shariati
Blvd,Shahrekord,Chaharmahal & Bakhtiari Province City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
۸۸۱۶۷۵۸۹۱۵ Phone
+98 38 3224 4194 Fax
dayani@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences Full name of responsible person
Mohammadali Dayani Position
Assistent professor
Latest degree Specialist
Other areas of specialty/work Radiology
Street address
Ayatalloh kashani hospital,parastar street,shehrekord town
City
Shahrekord Province
Chahar-Mahal-va-Bakhtiari Postal code
۸۸۱۶۷۵۸۹۱۵ Phone
+98 38 3224 4194 Fax
dayani@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD) Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available Statistical Analysis Plan
Yes - There is a plan to make this available Informed Consent Form
Yes - There is a plan to make this available Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available Data Dictionary
Yes - There is a plan to make this available Title and more details about the data/document
In the form ofThesis
When the data will become available and for how long
1397
To whom data/document is available For all audiences
Under which criteria data/document could be used For all audiences
From where data/document is obtainable Shahrekord Medical University
What processes are involved for a request to access data/document
In the form ofThesis Comments
